Absorption, Metabolism and Excretion of Apigenin and Apigenin Glycosides

NCT ID: NCT03526081

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-20

Study Completion Date

2016-07-30

Brief Summary

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Probe dietary intervention study in healthy young adult males to evaluate the concentration of apigenin derived metabolites in plasma and urine after single acute intakes of different apigenin-containing test materials.

Detailed Description

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Flavonoids, including the sub groups of Flavones (FO) are plant-derived compounds commonly present in the human diet. Examples of FO-containing foods and beverages are parsley, celery, and chamomile. The study described below will provide initial information of apigenin derived metabolites in humans. The investigators suggest the information that will be obtained from the outlined work will be particularly timely given increasing interest in the putative health effects of FO intake in humans.

This study consisted of two parts. The first part consisted of a probe study in which the investigators investigated the absorption and metabolism from four flavone-containing test products. The second phase investigated absorption and metabolism after the intake of a flavone-containing parsley drink.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Cross-over dietary intervention study in healthy young adult males
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators
Investigator doing data analysis and statistical analyses

Study Groups

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Chamomile Tea

Chamomile Tea in 300mL hot water

Group Type EXPERIMENTAL

Chamomile Tea

Intervention Type OTHER

Chamomile Tea in 300mL hot water

Parsley based drink

3.2 g dried parsley in 300mL hot water

Group Type EXPERIMENTAL

Parsley based drink

Intervention Type OTHER

3.2 g dried parsley in 300mL hot water

Parsley Yogurt

3.2 g dried parsley in 100g plain yogurt

Group Type EXPERIMENTAL

Parsley Yogurt

Intervention Type OTHER

3.2 g dried parsley in 100g plain yogurt

Apigenin

Apigenin capsule mixed with 300mL hot water

Group Type EXPERIMENTAL

Apigenin

Intervention Type OTHER

Apigenin capsule mixed with 300mL hot water

Parsley-based drink (II)

3.2 g of dried parsley in 300 ml of hot water

Group Type EXPERIMENTAL

Parsley-based drink (II)

Intervention Type OTHER

3.2 g dried parsley in 300mL hot water

Interventions

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Chamomile Tea

Chamomile Tea in 300mL hot water

Intervention Type OTHER

Parsley based drink

3.2 g dried parsley in 300mL hot water

Intervention Type OTHER

Parsley Yogurt

3.2 g dried parsley in 100g plain yogurt

Intervention Type OTHER

Apigenin

Apigenin capsule mixed with 300mL hot water

Intervention Type OTHER

Parsley-based drink (II)

3.2 g dried parsley in 300mL hot water

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* No prescription medications
* BMI 18.5 - 29.9 kg/m2
* Weight ≥ 110 pounds
* previously consumed cocoa, peanut, parsley, celery and chamomile products with no adverse reactions

Exclusion Criteria

* Adults unable to consent
* Prisoners
* Non-English speaking
* BMI ≥ 30 kg/m2
* Performing vigorous physical activity (i.e. more than 6 metabolic equivalence of task (MET) as defined by Centers for Disease Control and Prevention (CDC) and American College of Sports Medicine (ACSM) guidelines) for more than 3 days a week
* Dietary allergies including those to nuts, cocoa and chocolate products, parsley, celery and chamomile.
* Active avoidance of coffee and caffeinated soft drinks
* Under current medical supervision
* A history of cardiovascular disease, stroke, renal, hepatic, or thyroid disease
* History of clinically significant depression, anxiety or other psychiatric condition
* History of Raynaud's disease
* History of difficult blood draws
* Indications of substance or alcohol abuse within the last 3 years
* Current use of herbal, plant or botanical supplements (multi-vitamin/mineral supplements are allowed)
* Blood Pressure \> 140/90 mm Hg
* GI tract disorders, previous GI surgery (except appendectomy)
* Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas)
* Diarrhea within the last 3 months, or antibiotic intake within the last 3 months
* Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individuals following diets with significant deviations from the average diet
* Metabolic panel and cholesterol results or complete blood counts that are outside of the normal reference range and are considered clinically relevant by the study physician
* Cold, flu, or upper respiratory condition at screening
* Currently participating in a clinical or dietary intervention study
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mars, Inc.

INDUSTRY

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl L Keen, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Javier I Ottaviani, PhD

Role: STUDY_DIRECTOR

Mars, Inc.

Locations

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Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis

Davis, California, United States

Site Status

UC Davis

Davis, California, United States

Site Status

Countries

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United States

References

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Schroeter H, Heiss C, Spencer JP, Keen CL, Lupton JR, Schmitz HH. Recommending flavanols and procyanidins for cardiovascular health: current knowledge and future needs. Mol Aspects Med. 2010 Dec;31(6):546-57. doi: 10.1016/j.mam.2010.09.008. Epub 2010 Sep 18.

Reference Type BACKGROUND
PMID: 20854838 (View on PubMed)

Ottaviani JI, Momma TY, Kuhnle GK, Keen CL, Schroeter H. Structurally related (-)-epicatechin metabolites in humans: assessment using de novo chemically synthesized authentic standards. Free Radic Biol Med. 2012 Apr 15;52(8):1403-12. doi: 10.1016/j.freeradbiomed.2011.12.010. Epub 2011 Dec 23.

Reference Type BACKGROUND
PMID: 22240152 (View on PubMed)

Koster H, Halsema I, Scholtens E, Knippers M, Mulder GJ. Dose-dependent shifts in the sulfation and glucuronidation of phenolic compounds in the rat in vivo and in isolated hepatocytes. The role of saturation of phenolsulfotransferase. Biochem Pharmacol. 1981 Sep 15;30(18):2569-75. doi: 10.1016/0006-2952(81)90584-0. No abstract available.

Reference Type BACKGROUND
PMID: 6946775 (View on PubMed)

McCullough ML, Chevaux K, Jackson L, Preston M, Martinez G, Schmitz HH, Coletti C, Campos H, Hollenberg NK. Hypertension, the Kuna, and the epidemiology of flavanols. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S103-9; discussion 119-21. doi: 10.1097/00005344-200606001-00003.

Reference Type BACKGROUND
PMID: 16794446 (View on PubMed)

Heiss C, Kleinbongard P, Dejam A, Perre S, Schroeter H, Sies H, Kelm M. Acute consumption of flavanol-rich cocoa and the reversal of endothelial dysfunction in smokers. J Am Coll Cardiol. 2005 Oct 4;46(7):1276-83. doi: 10.1016/j.jacc.2005.06.055.

Reference Type BACKGROUND
PMID: 16198843 (View on PubMed)

Borges G, Fong RY, Ensunsa JL, Kimball J, Medici V, Ottaviani JI, Crozier A. Absorption, distribution, metabolism and excretion of apigenin and its glycosides in healthy male adults. Free Radic Biol Med. 2022 May 20;185:90-96. doi: 10.1016/j.freeradbiomed.2022.04.007. Epub 2022 Apr 20.

Reference Type DERIVED
PMID: 35452808 (View on PubMed)

Other Identifiers

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429275-10

Identifier Type: -

Identifier Source: org_study_id

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